510(k) · Cleared

Cleared

Click'x Monoaxial Screws and Hooks

K031175510(k) TraditionalCleared Nov 14, 2003214-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes (Usa) · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Nov 14, 2003 after a 214-day review. The FDA summary names no predicate by number. 2 of the 929 devices in its family, counting itself, have a Class I recall. 928 later devices descend from it.

Decided: Nov 14, 2003
Review: 214 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 0

928 later devices descend from it, 20 citing it directly. 2 of the 929 devices in this family, counting this one, have a Class I recall.

This deviceK031175 Click'x Monoaxial Screws and HooksSynthes (Usa) · 2003
Descendant · cites it directly · 659 of its ownK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
Descendant · 2 generations on · 581 of its ownK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
Descendant · cites it directly · 562 of its ownK052151 Synthes Pangea Monoaxial SystemSynthes Spine Co.Lp · 2005
Descendant · cites it directly · 551 of its ownK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
Descendant · 2 generations on · 549 of its ownK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005

Showing 5 of 928 descendants. See all descendants

Descendants cleared per year

2004high 88 (2023) · low 2 (2004)2026

Class I recalls in this family

K100952 Modification to Synthes Matrix System2 generations on · 2010
K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 928 · See all

K082572Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008 · cites it directly659descendants
K091445CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010 · 2 generations on581descendants
K052151Synthes Pangea Monoaxial SystemSynthes Spine Co.Lp · 2005 · cites it directly562descendants
K040442Protex Stabilization SystemGlobus Medical, Inc. · 2004 · cites it directly551descendants
K052069Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005 · 2 generations on549descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K031175	Click'x Monoaxial Screws and Hooks	Synthes (Usa)	2003	—
+1	K082572	Uss Iliosacral, Uss Polyaxial	Synthes Spine	2008	—
+2	K091445	CD Horizon Spinal System	Medtronic Sofamor Danek	2010	—
+1	K052151	Synthes Pangea Monoaxial System	Synthes Spine Co.Lp	2005	—
+1	K040442	Protex Stabilization System	Globus Medical, Inc.	2004	—
+2	K052069	Protex Stabilization System with Additional Componentes	Globus Medical, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	4	0
2006	4	0
2007	5	0
2008	15	0
2009	9	0
2010	16	1
2011	22	0
2012	31	0
2013	43	0
2014	45	0
2015	54	0
2016	49	0
2017	57	0
2018	60	0
2019	44	0
2020	57	0
2021	46	1
2022	63	0
2023	88	0
2024	77	0
2025	69	0
2026	68	0

FIG. 1 — Lineage of K031175, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (928)

See all 928

20 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K082572	Uss Iliosacral, Uss Polyaxial	Synthes Spine	2008	659
K052151	Synthes Pangea Monoaxial System	Synthes Spine Co.Lp	2005	562
K040442	Protex Stabilization System	Globus Medical, Inc.	2004	551
K082914	Clampfix	Synthes Spine	2008	350
K100634	Synthes Matrix System	Synthes (Usa)	2010	316
K070973	Quantum Spinal System	Pioneer Surgical Technology	2007	178
K124058	Creo Stabilization System	Globus Medical, Inc.	2013	172
K111358	Synthes Uss	Synthes Spine	2011	151
K113149	Synthes Uss Connectors	Synthes Spine	2012	93
K113044	Synthes Mirs	Synthes Spine	2011	93

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K082572 (Synthes Spine, 2008) has gone furthest, with 659 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007high 186 (2010) · low 50 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWP

2in 2022

2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	14	96	2	210
2008	13	50	1	594
2009	12	89	23	682
2010	14	186	2	474
2011	12	67	6	792
2012	18	112	1	918
2013	12	99	3	1,090
2014	13	138	0	1,022
2015	9	113	1	1,348
2016	0	—	3	1,379
2017	0	—	0	864
2018	0	—	1	657
2019	0	—	2	518
2020	0	—	0	796
2021	0	—	0	525
2022	0	—	2	335
2023	0	—	0	332
2024	0	—	0	436
2025	0	—	0	494
2026	0	—	0	—

What is it indicated for?

Read the full statement (276 words)

The Synthes USS (including the Click'X and USS VAS variable axis components), Click'X Monoaxial, Dual Opening and the Small Stature USS (which includes small stature and pediatric patients) are non-cervical spinal fixation devices intended for use as a posterior pedicle screw fixation systems (TI-S2), a posterior hook fixation systems (TI-L5), or as anterolateral fixation systems (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5/6.0-mm parallel connectors, the Synthes USS (including the Click'X and USS VAS variable axis components), Click'X Monoaxial and Dual Opening USS can be linked to the Cervifix system. In addition, when used with 3 3 5 . 0 mm parallel connectors, the Synthes Small Stature USS, can be linked to the CerviFix System. When used with the 5.016.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including the Click'X and USS VAS variable axis components), the Click'X Monoaxial and Dual Opening USS Systems.

In addition, Synthes USS (including the Click'X and USS VAS variable axis components), Click'X Monoaxial and the Dual Opening USS can be interchanged with all USS 6.0mm rods and transconnectors.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031175 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031175: Click'x Monoaxial Screws and Hooks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031175

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026